COBAS® TaqMan® HIV-1 Test For Use With The High Pure System

Human Immunodeficiency Virus Type 1 (HIV-1) viral load quantification.

An in vitro nucleic acid amplification test for the quantitation of HIV-1 RNA in human EDTA Plasma

The High Pure System Viral Nucleic Acid Kit allows manual specimen preparation and the COBAS® TaqMan® 48 Analyzer automates amplification and detection.

To assess patient prognosis or to monitor the effects of anti-retroviral therapy, the test measures the baseline HIV-1 RNA level by measuring changes in plasma HIV-1 RNA levels during the course of anti-retroviral treatment.

Features and Benefits

  • Delivers highly accurate results faster – an important advantage for clinicians
  • Highly sensitive and accurate
  • Minimizes testing errors with closed-tube amplification and detection on the COBAS® TaqMan® 48 Analyzer
  • Improves result integrity – AmpErase enzyme reduces the risk of cross-contamination of samples or labs
  • Provides a broader range of viral load data than earlier generation tests

Intended Use

The test is intended to be used in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients.

The COBAS® TaqMan® HIV-1 Test For Use With The High Pure System (CE-IVD) is not intended to be used as a screening test for blood or blood products for the presence of HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.

Not available in the United States.